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Patients with metastatic colorectal cancer sought for study of new drug

GRAND RAPIDS, MICH., September 29, 2003 -- Spectrum Health Cancer Center officials announced that they are enrolling patients for two new clinical research trials for colorectal cancer. They will test a new drug's ability to limit or halt the growth of new blood vessels in tumors and are looking for patients who wish to participate.

The studies are called CONFIRM 1 and CONFIRM 2, an acronym of Colorectal Oral Novel Therapy for the Inhibition of Angiogenesis and Retarding of Metastases. It is hoped the drug will promote anti-angiogenesis.

Tumor angiogenesis is the rapid growth of a network of blood vessels that penetrates into cancerous growths, which allows the tumor to grow and spread. This drug may interfere with the growth of new blood vessels, which might stop tumor growth or even shrink the tumor by depriving it of nutrients and oxygen supplied by blood vessels.

The drug being studied is referred to as PTK787/ZK222584. Patients accepted into the studies will receive either this drug or a placebo, along with 5-fluorouracil/leucovorin/oxaliplatin, known as the FOLFOX-4 regimen. This investigative drug has the potential to be the first orally active angiogenesis inhibitor to be used long-term in combination with standard chemotherapy for the treatment of patients with colorectal cancer that has spread to other areas of the body.

The CONFIRM 1 trial is designed for patients with cancer of the colon or rectum which has spread to other areas of the body and who have not yet been treated for the spread. It is scheduled to enroll approximately 1090 patients worldwide.

The CONFIRM 2 trial will examine the effects of the drug in patients who have already been treated for colorectal cancer that has spread. Investigators hope to enroll 830 patients in the study worldwide.

Spectrum Health is one of approximately 150 centers worldwide involved with this trial. The principal investigator is Oncologist Lawrence Pawl, MD. Spectrum Health is the first center in Michigan participating in this trial.

There were almost 500,000 cases of colorectal cancer worldwide in 2000, according to the World Health Organization. The American Cancer Society says that the disease is the third leading cause of cancer related death for both men and women.

Patients and family members can learn more about the trials by calling the Spectrum Health Cook Research Department at 616-391-3050. The study is being conducted in West Michigan at Spectrum Health hospitals by Spectrum Health-affiliated oncologists. For participating centers outside of West Michigan, patients should call 1-800-340-6843.

Source: Spectrum Health

Posted: September 2003